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KeratoconusPhase 3CXLNCT03080077

Safety and Effectiveness of Corneal Crosslinking (CXL): Keratoconus and Post-Refractive Ectasia

A Phase 3 study testing Ricrolin+ and Epi-Off in people with Keratoconus and Ectasia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This prospective, randomized study is being conducted to evaluate the safety and effectiveness of corneal cross-linking (CXL) in patients with keratoconus or post-refractive ectasia (post-LASIK or PRK) utilizing two techniques: the "standard" Epi-Off technique or an Epi-On technique that utilizes iontophoresis (I-CXL)… Read more about this study

Who is it for?
Ages 10 years and older
Conditions the study is for
Keratoconus, Ectasia
What is being tested?
Ricrolin+ and Epi-Off
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Jun 2016to Jun 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 10 years of age or older
  • Understand and have signed written IRB-approved informed consent
  • Willingness and ability to comply with schedule for follow-up visits
  • Having a diagnosis of keratoconus or post-refractive corneal ectasia (post-LASIK or PRK)
  • Presence of central or inferior steepening on the Pentacam map
  • Axial topography consistent with keratoconus or post-refractive corneal ectasia (post-LASIK or PRK)
Show all 30Show fewer
  • Presence of one or more slit lamp findings associated with keratoconus, such as:
  • Scissoring of the retinoscopic reflex
  • Fleischer ring
  • Vogt striae
  • Corneal thinning
  • Corneal scarring
  • BSCVA 20/20 or worse (<58 letters on ETDRS chart).
  • Contact lens wearers only: Removal of contact lenses for the required period of time prior to the first refraction:
  • Contact Lens Type Minimum Discontinuation Time Soft 3 Days Soft Extended Wear 1 Week Soft Toric 2 Weeks Rigid gas permeable 2 Weeks Hybrid lenses (SynergEyes; Rose K; Clear Kone) 2 Weeks Scleral Lenses 2 Weeks
  • Exclusion Criteria: All subjects meeting any of the following criteria will be excluded from the study:
  • A history of previous corneal surgery in the eye to be treated (including previous CXL treatment)
  • Eyes with episodes of hydrops or scarring from hydrops may be included as long as there is no active inflammation
  • Corneal pachymetry < 400 microns at the thinnest point measured by Pentacam
  • Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications or prevent the possibility of improved vision, for example:
  • History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.)
  • Clinically significant corneal scarring in the treatment zone
  • A history of chemical injury or delayed epithelial healing in the eye(s) to be treated
  • Pregnancy (including plan to become pregnant) or lactation during the procedure
  • A known sensitivity to study medications
  • Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests
  • A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing
  • Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study
  • Inability to cooperate with diagnostic tests or inability to understand the informed consent.
  • Concurrent use of systemic (including inhaled) medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

This prospective, randomized study is being conducted to evaluate the safety and effectiveness of corneal cross-linking (CXL) in patients with keratoconus or post-refractive ectasia (post-LASIK or PRK) utilizing two techniques: the "standard" Epi-Off technique or an Epi-On technique that utilizes iontophoresis (I-CXL) to deliver the riboflavin to the cornea without need for removal of the corneal epithelium. Patients will be randomized to receive CXL treatment with either the Epi-On or Epi-Off technique.

Conditions
Keratoconus, Ectasia
Being tested
Ricrolin+, Epi-Off
Medical subject headings
Keratoconus, Dilatation, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ricrolin+Drug

    Also called Epi-on (iontophoresis)

    The IONTOPHOR CXL iontophoresis applicator and the associated blepharostat will be placed onto the cornea to be treated. The applicator will be secured to the cornea and filled with Ricrolin+ which as been aspirated from the bottle using a syringe with a needle. The generator will be switched on and set to 1 mA for 5 minutes. The generator will then be disconnected and the applicator will be removed from the cornea.

  • Epi-OffDrug

    Using topical anesthesia (proparacaine), the surgeon will create a complete corneal abrasion to facilitate riboflavin diffusion into the cornea. The epithelium will be removed by gently brushing the cornea with a scalpel. A corneal abrasion diameter of ~9mm is recommended, which may be adjusted as needed at the discretion of the investigator to accommodate individual eye geometry. Ultrasound corneal pachymetry should be performed before dis-epithelialization and after dis- epithelialization. Local anesthetics will be administered as needed to maintain patient comfort during the CXL procedure.

Study groups in NCT03080077
Study groupRoleWhat they receive
Epi-Off CXLActive comparatorUsing topical anesthesia (proparacaine), the surgeon will create a complete corneal abrasion to facilitate riboflavin diffusion into the cornea. The epithelium will be removed by gently brushing the cornea with a scalpel. A corneal abrasion diameter of ~9mm is recommended, which may be adjusted as needed at the discretion of the investigator to accommodate individual eye geometry. Ultrasound corneal pachymetry should be performed before dis-epithelialization and after dis- epithelialization. Local anesthetics will be administered as needed to maintain patient comfort during the CXL procedure.
Receives: Drug: Epi-Off
Epi-On CXLExperimentalThe IONTOPHOR CXL iontophoresis applicator and the associated blepharostat will be placed onto the cornea to be treated. The applicator will be secured to the cornea and filled with Ricrolin+ which as been aspirated from the bottle using a syringe with a needle. The generator will be switched on and set to 1 mA for 5 minutes. The generator will then be disconnected and the applicator will be removed from the cornea.
Receives: Drug: Ricrolin+

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Kmax

    Kmax = maximum simulated keratometry value

    Measured: baseline and 2 years

Secondary outcomes (8)

  1. Change in steepest K

    steepest K is the higher diopter number which represents the steepest meridian of the cornea

    Measured: baseline and 2 years

  2. Change in astigmatism

    Astigmatism is an imperfection in the curvature of the cornea, causing a refractive error diagnosed by standard eye exam with refraction test.

    Measured: baseline and 2 years

  3. Change in keratometry

    Keratometry is the measurement of the corneal radius of curvature

    Measured: baseline and 2 years

  4. Change in pachymetry

    Pachymetry is a common test for glaucoma and measures the thickness of the cornea

    Measured: baseline and 2 years

  5. Changes in curvature

    Shape of cornea

    Measured: baseline and 2 years

  6. Change in sphere

    Change in refraction

    Measured: baseline and 2 years

  7. Change in cylinder

    Cylinder is the amount of astigmatism that is present

    Measured: 2 years

  8. Change in BCVA

    Best-corrected visual acuity (BCVA)

    Measured: baseline and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2017
  2. Study startJun 2016
  3. Primary completionJun 2019 (estimated)
  4. Study completionJun 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03080077
Sponsor's protocol ID
GCO 16-0627
Acronym
CXL
Status last verified
Jun 2018
First submitted
6 Mar 2017
Last updated
7 Jun 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Lombardo M, Serrao S, Rosati M, Ducoli P, Lombardo G. Biomechanical changes in the human cornea after transepithelial corneal crosslinking using iontophoresis. J Cataract Refract Surg. 2014 Oct;40(10):1706-15. doi: 10.1016/j.jcrs.2014.04.024.

    PubMed 25263041

  • Koller T, Schumacher S, Fankhauser F 2nd, Seiler T. Riboflavin/ultraviolet a crosslinking of the paracentral cornea. Cornea. 2013 Feb;32(2):165-8. doi: 10.1097/ICO.0b013e318269059b.

    PubMed 23187160

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ricrolin+ and Epi-Off in people with Keratoconus and Ectasia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Kmax (time frame: baseline and 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03080077, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2018.

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